An Open-Label, Randomized, Two-Period, Crossover Study to Characterize the Insulin Exposure and Glucose Response to Meals in Type 1 Diabetic Subjects Administered Two Different Insulin Regimens Compared to the Endogenous Insulin Exposure and Glucose Response to Meals In Healthy Adult Controls
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 24
- 主要终点
- Insulin levels
研究概览
简要总结
Intensive control of Type 1 Diabetes is critical in prevention of long term complications. Unfortunately, there is a three-fold increase in hypoglycemia with intensive control. Hypoglycemia is often the major limiting factor in achieving good control. Insulin treatment of diabetes is composed of some form of short acting insulin regimen in order to provide control of blood glucose excursions that are the result of glucose intake as well as a basal insulin regimen either in a continuous administration (as in continuous subcutaneous insulin infusion-"pump therapy"), once a day injection (insulin Glargine), twice a day (ultralente or NPH or lente insulin) or a premixed version that is combined with the short acting insulin (70/30 or 75/25). Often low blood sugars are the result of less physiologically absorbed insulins whose peak of action is earlier or later than the peak absorption of glucose from a meal.
Apidra (glulisine insulin) is a new short acting insulin analogue whose peak and duration of action are ideal in that it may be administered more appropriately prior to and even after a meal with evidence of good control of blood glucose excursions from a meal. The purpose of this study is to compare the effect of Apidra upon meal related blood glucose profile as compared to those treated with 70/30 insulin in patients with Type 1 Diabetes. The investigators also will study healthy volunteers as controls who will not be treated with insulin but will be evaluated for mealtime absorption and blood glucose profile during similar meal intake. The investigators will use a stable isotope tritiated glucose.
详细描述
Intensive control of Type 1 Diabetes is critical in prevention of long term complications. Unfortunately, there is a three-fold increase in hypoglycemia with intensive control. Hypoglycemia is often the major limiting factor in achieving good control. Insulin treatment of diabetes is composed of some form of short acting insulin regimen in order to provide control of blood glucose excursions that are the result of glucose intake as well as a basal insulin regimen either in a continuous administration (as in continuous subcutaneous insulin infusion-"pump therapy"), once a day injection (insulin Glargine), twice a day (ultralente or NPH or lente insulin) or a premixed version that is combined with the short acting insulin (70/30 or 75/25). Often low blood sugars are the result of less physiologically absorbed insulins whose peak of action is earlier or later than the peak absorption of glucose from a meal.
Apidra (glulisine insulin) is a new short acting insulin analogue whose peak and duration of action are ideal in that it may be administered more appropriately prior to and even after a meal with evidence of good control of blood glucose excursions from a meal. The purpose of this study is to compare the effect of Apidra upon meal related blood glucose profile as compared to those treated with 70/30 insulin in patients with Type 1 Diabetes. We also will study healthy volunteers as controls who will not be treated with insulin but will be evaluated for mealtime absorption and blood glucose profile during similar meal intake. We will use a stable isotope tritiated glucose.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Diabetic Subjects
- •12 adults (males or females) with Type 1 Diabetes, aged 18 to 55 years.
- •C-peptide-negative
- •Body mass index < 29.0 kg/m2
- •Healthy Subjects
- •12 non-smoking adults (males or females), aged 18 to 55 years
- •Normal response to an oral glucose tolerance test (OGTT)
- •Body mass index < 29.0 kg/m2
排除标准
- •Diabetic Subjects
- •Hemoglobin A1c >9%
- •Total daily insulin requirements >0.8 units/kg actual body weight
- •History of hypoglycemia that required the subject to see medical attention (i.e., doctor's office visit, ER visit, or EMT/paramedic attention) within 6 months of the study.
- •History of acute metabolic complications within 3 months of the study
- •History of lipodystrophy.
- •History of or suspected diabetic gastroparesis or current treatment with any drugs known to affect gastrointestinal motility.
- •Inability or unwillingness to administer subcutaneous insulin injections in the abdomen.
- •Any past or present clinically relevant abnormality, medical condition, or circumstance making the subject unsuitable for participation in the study.
- •Active peptic ulcer disease or a history of gastrointestinal surgery within the last 6 months years.
- •History of malignancy (except basal cell carcinoma and carcinoma in situ) within the last 5 years.
- •Pregnant or lactating females or females of childbearing potential who are unwilling to abstain from sexual intercourse or use reliable, medically accepted methods of contraception.
- •History of alcoholism or drug abuse within 12 months of the study.
- •Is the investigator, sub-investigator, research assistant, pharmacist, study coordinator, other study staff, or relative thereof directly involved in the conduct of this protocol.
- •Healthy Subjects
- •Hemoglobin A1c >6.0%
- •Any past or present clinically relevant abnormality, medical condition, or circumstance making the subject unsuitable for participation in the study.
- •Historical, clinical, or laboratory evidence of liver disease including but not limited to transaminase activity concentrations >2.5 times the upper limit of the reference range.
- •Current treatment with any drugs known to affect gastrointestinal motility.
- •Active peptic ulcer disease or a history of gastrointestinal surgery within the last 6 months.
- •History of malignancy (except basal cell carcinoma and carcinoma in situ) within the last 5 years.
- •Pregnant or lactating females or females of childbearing potential who are unwilling to abstain from sexual intercourse or use reliable, medically accepted methods of contraception.
- •History of alcoholism or drug abuse within 12 months of the study.
- •Is the investigator, sub-investigator, research assistant, pharmacist, study coordinator, other study staff, or relative thereof directly involved in the conduct of this protocol.
研究组 & 干预措施
Apidra (insulin glulisine)
Administration of Apidra at three meals during a 24 hour period.
干预措施: Insulin glulisine (Drug)
70/30 insulin
Administration of 73/30 insulin at three meals during a 24 hour period.
干预措施: Insulin (Drug)
结局指标
主要结局
Insulin levels
时间窗: 24 hours
次要结局
未报告次要终点
研究者
Steve Davis
Department Chair
Vanderbilt University